Phase 3
N=49
An Extension Study of WA19926 of the Long-Term Safety of Tocilizumab (RoActemra/Actemra) in Patients With Early Moderate to Severe Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01664598 ↗Enrolled (actual)
49
Serious AEs
10.2%
Results posted
Dec 2023
Primary outcome: Primary: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs) — 69.4; 10.2; 17.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tocilizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs) |
69.4; 10.2; 17.2 | — |
| PRIMARY Percentage of Adverse Events (AEs) Leading to Dose Modification and AEs Leading to Study Withdrawal |
34.5; 1.1 | — |
| PRIMARY Percentage of Adverse Events With Severity as Mild, Moderate, and Severe |
62.1; 36.8; 1.1 | — |
| SECONDARY Percent Change From Baseline in the Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Over Time |
-35.4; -27.2; -29.3; -24.6; -32.5; -38.3 | — |
| SECONDARY Percent Change From Baseline in the Simplified Disease Activity Index (SDAI) Over Time |
-45.5; -34.7; -6.3; -12.4; -39.3; -47.3 | — |
| SECONDARY Change From Baseline in Tender Joint Count 66 (TJC 66) Over Time |
-5.0; -5.7; -6.6; -6.2; -6.7; -6.6 | — |
| SECONDARY Change From Baseline in Swollen Joint Count 66 (SJC 66) Over Time |
-3.5; -3.7; -4.5; -4.6; -4.7; -4.9 | — |
| SECONDARY Percentage of Participants With Treatment-Free Remission According to DAS28-ESR/SDAI Remission Criteria |
71.4 | — |
| SECONDARY Time to Rheumatoid Arthritis Recurrence in Participants Who Achieved Treatment-Free Remission |
23 | — |
| SECONDARY Percent Change in Participant's General Assessment of Disease Activity (Severity of Disease) VAS Over Time |
-19.6; -20.3; -17.5; 6.1; -14.2; -19.3 | — |
| SECONDARY Percent Change in Participant's Assessment of Pain (VAS) Over Time |
-21.8; -20.3; -25.4; 4; -19.8; -19.9 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ-DI) Score Over Time |
-0.2; -0.2; -0.1; 0.0; -0.1; -0.2 | — |
Summary
This open-label, single arm, multicenter long-term extension study of WA19926 evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis who completed the 104-week WA19926 core study. Eligible patients received tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.
Eligibility Criteria
Inclusion Criteria
- Adult participants, >/= 18 years of age
- Participants who complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
- No current or recent adverse event or laboratory finding preventing the use of the study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit
- Women of childbearing potential must agree to use adequate contraception as defined by protocol during the treatment period
Exclusion Criteria
- Pregnant females
- Participants who have withdrawn prematurely from the WA19926 core study for any reason
- Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926
- Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926
- Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926
- Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
- Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients
- Evidence of severe uncontrolled concomitant disease or disorder
- Known active or history of recurrent infections
- Active tuberculosis requiring treatment in the previous 3 years
- History of alcohol, drug or chemical abuse since inclusion in the WA19926 study
Data sourced from ClinicalTrials.gov (NCT01664598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.